Post-Approval Studies (PAS)

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

A total of 150 patients had their 60-month visits and 5 did not complete their echocardiograms. The rate of complete closure of the ductus arteriosus at 60 months post-procedure was 100% (145/145).

Study Strengths & Weaknesses

The study had a low rate of attrition, thus minimizing selection bias. It also provided results on the long- term (5 years) safety and efficacy of the device. A weakness of this study is that it did not collect data on race and/or ethnicity.

Recommendations for Labeling Changes

A labeling change is recommended to add the long-term safety and efficacy results from the pre-market cohort.